HS-18-633
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
IRAS ID
269333
Contact name
Annette Mattsson
Contact email
Sponsor organisation
Camurus AB
Eudract number
2019-001191-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
The study is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy and safety of CAM2029, administered as subcutaneous injection every 4 weeks, versus placebo in patients with acromegaly. Patients who are on treatment with long-acting somatostatin analogues and have prior evidence of active acromegaly disease will be randomized to treatment with either CAM2029 or placebo in a 24-week double-blind treatment phase. The primary objective of the study is to assess the superiority of CAM2029 compared to placebo in biochemical response for IGF-1. The safety and tolerability of CAM2029 will also be assessed, together with patient-reported treatment satisfaction and health-related quality of life parameters.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0061
Date of REC Opinion
21 Feb 2020
REC opinion
Favourable Opinion